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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph, Ambulatory (Without Analysis)
510(k) Number K993643
Device Name NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100
Applicant
Nexan Telemed , Ltd.
15825 Shady Grove Rd.
Suite 130
Rockville,  MD  20850
Applicant Contact KENNETH PALMER
Correspondent
Nexan Telemed , Ltd.
15825 Shady Grove Rd.
Suite 130
Rockville,  MD  20850
Correspondent Contact KENNETH PALMER
Regulation Number870.2800
Classification Product Code
MWJ  
Date Received10/28/1999
Decision Date 12/28/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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